Datascope Intra-Aortic Balloon Pumps Recalled After 4 Serious Injuries, 1 Death

Mealey's (February 1, 2023, 8:18 AM EST) -- SILVER SPRING, Md. — Datascope Corp. has recalled more than 4,400 of its Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue IABP heart devices because leaks from the balloon component have resulted in 134 complaints, including 12 device shutdowns, four serious injuries and one death, the Food and Drug Administration said in a safety communication....

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